ISSUE 6 VOLUME 12 DECEMBER 2018 u Formulary Additions ...... 1 - 2 u Formulary Removals ...... 3 u Interregional Practice Recommendations ...... 3 u Prior Authorization (QRM) Additions & Changes ...... 3 - 4 u New Standing Order ...... 4 u 2019 Formulary Changes...... 4 u National Medicare Part D Formulary ...... 5 u Introducing Alvesco HFA ...... 6 u Appendix A: 2019 Step Therapy Changes...... 7 Formulary At A GlanceUpdate

Formulary Additions The following will be added to the Commercial Formulary effective January 1, 2019: • Doxazosin (generic Cardura) 1 mg, 2 mg, 4 mg & 8 mg tablets: Doxazosin is a non-selective alpha1-adrenergic antagonist indicated for the treatment of benign prostatic hyperplasia (BPH) and treatment of hypertension. All alpha1-adrenergic antagonists have similar efficacy for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Due A PUBLICATION OF THE GEORGIA PHARMACY to recent price changes, doxazosin is now more than 3 times less than the cost of terazosin. AND THERAPEUTICS (P&T) COMMITTEE. The Formulary Update contains information regarding formulary Addition of doxazosin to the formulary will provide an additional option for the treatment additions, deletions, exclusions, brief descriptions of of BPH. products, and current drug related news. It also lists • Alfuzosin (generic Uroaxtral) 10 mg tablet: Alfuzosin is a uroselective alpha -adrenergic items to be discussed at upcoming P&T meetings. Please 1 refer to the web site http://kpnet.kp.org:81/ga/healthcare/ antagonist indicated for the treatment of benign prostatic hyperplasia (BPH). Current formularies.html or providers.kp.org for the full KP GA Drug medications for the treatment of BPH on the KPGA Commercial Formulary are tamsulosin Formulary. If you have Lexi-Comp PDA access to the KPGA and terazosin. All alpha -adrenergic antagonists have similar efficacy for the treatment Online Formulary, remember to sync your device for the 1 most current information. of lower urinary tract symptoms (LUTS) secondary to BPH. Due to recent price changes, alfuzosin is now two times less costly than terazosin and is similar in cost to tamsulosin. Kaiser Permanente Georgia 1 Formulary Additions, Continued Upcoming Additionally, alfuzosin offers a cost savings for patients requiring the maximum dose of tamsulosin (0.8 mg daily) for BPH treatment. Addition of alfuzosin to the formulary provides an additional treatment Formulary Items option for BPH for patients who require the maximum tamsulosin dose or who are intolerant to tamsulosin. • Darifenacin (generic Enablex) 7.5 mg & 15 mg tablets: Darifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. Current OAB agents on the KPGA Commercial Formulary include oxybutynin IR/ER and trospium IR/XR. Pharmacotherapy is the second-line treatment option for OAB in patients who fail non-pharmacological behavior therapy. In general, antimuscarinics used for OAB treatment have a modest benefit over placebo. Due to their similar efficacy, guidelines recommend selection based on patient-specific characteristics and history of trial/intolerance to antimuscarinics. Due to recent contract changes, the cost of darifenacin has decreased and is now 4 times less than trospium ER and at least 13 times less than branded OAB agents. Addition of darifenacin to the formulary provides a lower cost alterative to generic and brand non-preferred OAB agents. An important aspect of the • Vancomycin (generic Vancocin) 125 mg & 250 mg capsules: Oral vancomycin is a glycopeptide formulary process is the involvement antibiotic used for the treatment of Clostridioides (formerly Clostridium) difficile infection (CDI) of all practitioners. Please contact and treatment of enterocolitis caused by Staphylococcus aureus. Orally administered vancomycin your P&T Committee representative is not effective for treatment of other types of infections that are susceptible to the intravenous or your clinical service chief by formulation. Updated CDI treatment guidelines were published by the Infectious Disease Society January 25th, 2019 if you wish to of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) in 2018. Based on comment on any of the medications, these guidelines, vancomycin is now considered a first line option for initial CDI episodes in adult class reviews, or other agenda items under consideration. To make and pediatric patients and is now preferred over metronidazole for adult patients. Additionally, formulary addition requests, you vancomycin may be considered for treatment of recurrent CDI episodes. Due to contract changes, must submit a Formulary Additions/ the cost of vancomycin oral capsules has decreased and is now more cost effective than the cost of Deletions Form and Conflict of vancomycin oral solution (brand Firvanq). Interest Form to Drug Information • (generic Copaxone) 40 mg/ml syringe: Glatiramer acetate (GA) is a disease Services or call (404) 949-5331. modifying therapy (DMT) indicated for relapsing forms of multiple sclerosis (MS). It is typically used as a first-line agent for patients with moderate disease activity. Currently, Extavia ( beta-1b) and Glatopa (glatiramer acetate) 20 mg are the first line, preferred DMTs on the KPGA Commercial Formulary. GA is favored over interferon beta in patients who have a relative contraindication or intolerance to interferon beta such as uncontrolled mood disorder, elevated transaminases or severe flu-like symptoms. GA 40 mg is injected three times a week, compared to the daily injection dosing regimen of GA 20 mg. Due to recent contract changes and availability of generic GA 40 mg, the cost of GA 40 mg is now comparable to current formulary DMTs for MS. Addition of generic GA 40 mg to the Commercial Formulary provides an additional DMT option for management of MS. Brand Copaxone will continue to require prior authorization. • Lugol’s solution: Potassium iodide 10% and iodine 5% (Lugol’s 5%) oral solution is an antithyroid agent used in preparation for thyroidectomy surgery. In patients with Grave’s disease, preoperative potassium iodide, saturated solution of potassium iodide (SSKI), or inorganic iodine is recommended to decrease thyroid blood flow, vascularity, and intraoperative blood loss during the thyroidectomy. Over the counter (OTC) SSKI was previously utilized for this indications, but the cost has increased significantly. Lugol’s solution provides a cost effective prescription option with standardized dosing for this indication. • Cosentyx (secukinumab) 150 mg injection: Cosentyx is a fully human immunoglobulin G1 (IgG1) monoclonal antibody antagonist of -17A (IL-17A) indicated for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy, adults with active psoriatic arthritis, and adults with active ankylosing spondylitis. A recent network meta-analysis found the interleukin-17A inhibitors (brodalumab, ixekizumab, and secukinumab) were more effective than ustekinumab and generally more effective than etanercept, adalimumab, and apremilast. Overall safety was comparable between the biologics. Due to contract change, Cosentyx is now comparable in cost to first line biologics for the treatment of plaque psoriasis. Addition of Cosentyx to the formulary provides an additional treatment option for patients with plaque psoriasis. • Dalfampridine (generic Ampyra) 10 mg tablet: Dalfampridine is a symptomatic treatment indicated to improve walking speed in patients with relapsing and progressive forms of multiple sclerosis. It is not an immunomodulatory drug and thus it is not a disease modifying therapy. Physical therapy is the only treatment alternative to dalfampridine and it is recommended before exposure to dalfampridine and concomitantly if possible. Addition of dalfampridine to the formulary provides a symptomatic treatment option for multiple sclerosis. The following medication was added to the Commercial Formulary effective November 1, 2018: • Alvesco (generic ciclesonide) 80 mcg & 160 mg MDI: Alvesco was approved for addition to the formulary at the August P&T meeting. See page 6, Introducing Alvesco, for additional information. 2 Kaiser Permanente Georgia Questions and Formulary Removals The following medication will removed from the Commercial Formulary effective January 1, 2019: Concerns? • Atripla (efavirenz, tenofovir disoproxil fumarate, and emtricitabine) tablet: Atripla is a single fixed- dose antiretroviral combination medication used for the treatment of human immunodeficiency virus (HIV). It consists of a non-nucleoside reverse transcriptase inhibitor (efavirenz) and two nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC)). A new formulation of tenofovir, tenofovir alafenamide (TAF), has been shown to decrease the risk of kidney and bone toxicities, compared to TDF, while maintaining efficacy against the HIV virus. The TAF/FTC backbone is available in fixed dose combination with other medications, including bictegravir (Biktarvy), elvitegravir/cobicistat (Genvyoa) which are available on the Commercial Formulary. For patients who wish to remain on Atripla, Symfi (efavirenz/tenofovir/lamivudine) is available at a generic copayment and is similar to Atripla. There is an ongoing interregional initiative to convert patients on Atripla to Biktarvy or Symfi for safety and cost savings. Removal of Atripla from If you have any questions or the Commercial Formulary helps to support these initiatives. concerns, please contact any of the following P&T Committee members and designated Interregional Practice Recommendations alternates: The Emerging Therapeutics Strategy (ETS) Program is a centralized effort that applies our evidence- P&T Chair: based model to develop interregional practice recommendations with KP physician specialists, coordinates KP HealthConnect clinical content for decision support, and monitors outcomes to Carole Gardner, MD measure uptake of the clinical and strategy recommendations. Through the collaboration of Pharmacy, P&T Committee Members: Permanente physicians, and Federation partners, the ETS Program offers a unified approach in the provision and management of specialty drugs, to help ensure that our members derive the greatest Debbi Baker, PharmD, BCPS value from these products. Clinical Pharmacy New Interregional Practice Recommendations have been approved for the following ETS Program Gary Beals, RPh Medications: Director of Pharmacy • Hereditary Transthyretin-mediated Amyloidosis (hATTR) drugs – Onpattro (patisiran) infusion and Tegsedi (inotersen) subcutaneous injections are indicated for treatment of the polyneuropathy Karen Bolden, RN, BSN of hereditary transthyretin-mediated amyloidosis in adults. Clinical Services Updated Interregional Practice Recommendations have been approved for the following ETS Alyssa Dayton, MD Program Medications: Obstetrics and Gynecology • Calcitonin gene-related peptide inhibitors (CGRP) – Updated to include new CGRP inhibitors, Carole Gardner, MD Anjovy (fremanezumab-vfrm) and Emgality (galcanezumab-gnlm), defined age range in inclusion Geriatric Medicine criteria, and clarified headache diary • Hemlibra (emicizumab-kxwh) – Guidelines updated to include new indication for use in Jay Polokoff, MD Hemophilia A with or without factor VIII inhibitors and new dosing regimens Pediatrics • Epidiolex (cannabidiol) – Guidelines updated to clarify therapy discontinuation criteria Craig Kaplan, MD Adult Primary Care Guidelines can be found here: https://sites.sp.kp.org/teams/npps/sitepages/home.aspx George Kawamura, MD Adult Primary Care New Prior Authorization (QRM) Medications Amy Levine, MD Certain medications require Quality Resource Management (QRM) review prior to coverage. The prior Pediatrics authorization process and criteria apply to all formularies except the Medicare Part D Formulary. A complete listing of prior authorization medications and their corresponding criteria is available on Felecia Martin, PharmD Pharmacy/Geriatrics the intranet under Healthcare Delivery/Guides & References/Formularies/Criteria Restricted (QRM) Medications. Shayne Mixon, PharmD Pharmacy Operations The following medications will be added to the list of Prior Authorization Medications Effective Rachel Robins, MD January 1, 2019: Hospitalist • Ilumya (tildrakizumab-asmn) - Treatment of adults with moderate-to-severe plaque psoriasis who Jennifer Rodriguez, MD are candidates for systemic therapy or phototherapy Behavioral Health • Jynarque (tolvaptan) – Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) Designated Alternates: • Saxenda (liraglutide) – Indicated as an adjunct to a reduced calorie diet and increased physical 2 2 Jacqueline Anglade, MD activity for chronic weight management in adult patients with BMI > 30 kg/m or >27 kg/m in the Obstetrics and Gynecology presence of at least one weight-related comorbid condition • Kevzara (sarilumab) – Indicated for treatment of moderate to severe active rheumatoid arthritis Lesia Jackson, RN in adults who have had an inadequate response or intolerance to one or more disease-modifying Clinical Services antirheumatic drugs • Diabetes Medications: Tradjenta (linagliptin), Jentadueto (linagliptin/metformin), Jardiance (empagliflozin)– Added back to Prior Authorization Medications

Kaiser Permanente Georgia 3 New Prior Authorization (QRM) Medications, Continued Class Review The following medications will be added to the list of Prior Authorization Medications Effective February 1, 2019: • Vemlidy (tenofovir alafenamide) – Indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease Changes to Prior Authorization (QRM) Medications Effective January 1, 2019: • Dupixent (dupilumab) – Updated to include new indication for add on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with corticosteroid dependent asthma • Glatiramer acetate 40 mg/ml – Prior authorization no longer required, added to KPGA Commercial Formulary • Cosentyx (secukinumab) – Prior authorization no longer required, added to KPGA Commercial February 2019: Formulary • DPP-IV Inhibitors and GLP-1 Agonists – Updated to remove commercial driver’s license as exclusion Medication Class Reviews for use of insulin prior Antianxiety Agents - Misc • SGLT2 Inhibitors – Updated to remove commercial driver’s license criteria as exclusion criteria utilization of insulin; Updated to note that patients should optimize use of first line CVDrisk Antidepressants reduction medications Antipsychotic/Antimanic • Calcitonin gene-related peptide inhibitors (CGRP) – Updated to align with changes made to Agents Interregional Practice Recommendations Migraine Products • Hemlibra (emicizumab-kxwh) – Updated to align with changes made to Interregional Practice Anticonvulsants Recommendations • Epidiolex (cannabidiol) – Updated to align with changes made to Interregional Practice Hematological Agents - Misc Recommendations Hypnotics Stimulants/ADHD Please see full QRM guidelines here: http://kpnet.kp.org:81/ga/healthcare/docs/drug/restrictedMedi- Psychotherapeutics - Misc cations.pdf Antiparkinsons New Standing Order Neuromuscular Blockers Antimyasthenics Fulphila (-jmdb) is biosimilar approved by the FDA, based on the reference product pegfil- grastim (Neulasta). Fulphila has no clinically meaningful difference in terms of safety and effectiveness Urinary Antiinfectives from pegfilgrastim (Neulasta). Urinary Antispasmodics Neulasta® Equivalent to Fulphila™ Genitourinary - Misc Neulasta® 6 mg/0.6 ml syringe ↔ Fulphila™ 6 mg/0.6 ml syringe Antiasthmatics Drugs Not Added to the Formulary • Fulphila (pegfilgrastim-jmdb) is the first biosimilar approved for pegfilgrastim, where the pegylated formulation allows for dosing once per treatment cycle as compared to , which is dosed multiple times per cycle. • Lucemyra (lofexidine) is a central alpha-2 adrenergic agonist indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. • Solosec (secnidazole) is an oral 5-nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis. • Juluca (dolutegravir/rilpivrine) is a fixed-dose two drug regimen indicated for the treatment of HIV- 1 infection to replace the current ARV in those who are virologically suppressed on a stable ARV for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the two components. Formulary Updates for 2019 • Federal Employee Health Benefit (FEHB) will move to a five-tier formulary with the addition of preferred generic Tier 1. The Federal Health Benefit Formulary can be found here: http://kpnet. kp.org:81/georgia/healthcare/docs/drug/FEHB_Drug_Formulary_v2.pdf • QHP and Dual Choice Formularies 2019 Step Therapy Changes - Step Therapy has been added to several new medications on the 2019 QHP and Dual Choice formularies to help align our open formulary benefit plans with our non-formulary medications on our closed benefit plans. Please see Appendix A for the new medications requiring step therapy in 2019. 4 Kaiser Permanente Georgia Medicare Part D Formulary Kaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T Committee reviews drugs and decides on tier status. The National Medicare Part D Pharmacy and Therapeutics Committee is charged with reconciling regional differences in MPD Formulary recommendations through consensus building in order to maintain one National MPD Formulary for Kaiser Permanente. New Medications - Protected Class: • Meropenem-vaborbactam (Vabomere) Intravenous – FDA approved for treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex • Vestronidase alfa-vjbk (Mepsevii) Intravenous – FDA approved for Indicated in pediatric and adult patients for the treatment of mucopolysaccharides VII (MPS VII, Sly syndrome) • Mylotarg (Gemtuzumab ozogamicin) Intravenous – FDA approved for treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test

Initial Tier Placements-Recently launched and approved medications Implementation Medication Name Tier Date sofosbuvir/velpatasvir 400 mg/100 mg tablets (generic Eclusa) Specialty Tier 5 11/21/2018 ledipasvir/sofosbuvir 90 mg/400 mg tablets (generic Harvoni) Specialty Tier 5 11/21/2018 revefenacin 175 mcg/3 mL inhalation solution (Yupelri) Specialty Tier 5 11/16/2018 elapegademase-lvlr 1.6 mg/mL injection (Revcovi) Specialty Tier 5 11/15/2018 aripiprazole 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablets (Abilify MyCite) Specialty Tier 5 11/14/2018 clobazam 5 mg, 10 mg, 20 mg oral film (Sympazan) Specialty Tier 5 11/8/2018 omalizumab 75 mg/0.5 mL, 150 mg/mL injection (Xolair) Specialty Tier 5 11/8/2018 lorlatinib 25 mg, 100 mg tablets (Lorbrena) Specialty Tier 5 11/8/2018 tbo-filgrastim 300 mcg/mL, 480 mcg/1.6 mL injection (Granix) Specialty Tier 5 11/5/2018 hydroxyurea 1000 mg tablets (Siklos) Specialty Tier 5 11/5/2018 testosterone enanthate 50 mg/0.5 mL, 75 mg/0.5 mL, 100 mg/0.5 mL injection (Xyosted) Non-Preferred Brand Tier 4 11/2/2018 halobetasol propionate 0.05% aerosol foam (Lexette) Specialty Tier 5 11/2/2018 everolimus 1 mg tablet (Zortress) Specialty Tier 5 10/26/2018 dupilumab 200 mg/1.14 mL injection (Dupixent) Specialty Tier 5 10/24/2018 inotersen 284 mg/1.5 mL injection (Tegsedi) Specialty Tier 5 10/24/2018 talazoparib tosylate 0.25 mg, 1 mg capsules (Talzenna) Specialty Tier 5 10/19/2018 immune globulin 1 gm/10 mL, 2.5 gm/25 mL, 5 gm/50 mL, 10 gm/100 mL, 20 gm/200 mL, 30 gm/300 mL injection (Panzyga) Specialty Tier 5 10/18/2018 moxetumomab pasudo-tox-tdfk 1 mg injection (Lumoxiti) Specialty Tier 5 10/18/2018 amikacin sulfate lipo-some 590 mg/8.4 mL inhaled suspesion (Ari-kayce) Specialty Tier 5 10/4/2018 macimorelin 0.5 mg solution (Macrilen) Non-Preferred Brand Tier 4 Pending

2019 MPD Tier Changes Albenza tabs 200 mg Tier 3 to Tier 5 Leukeran tabs 2 mg Tier 3 to Tier 5 Edecrin tabs 25 mg Tier 3 to Tier 5 Invega Sustenna susp 117 mg, 156 mg, & 234 mg Tier 4 to Tier 5 Glumetza tb24 500 mg & 1000 mg Tier 4 to Tier 5 Metformin hcl er (mod) tb24 500 mg & 1000 mg Tier 2 to Tier 5 Caspofungin acetate 50 mg & 70 mg Tier 4 to Tier 5 Zileuton 600 mg Er Tab Tier 2 to Tier 5 Palonosetron inj 0.25/2ml Tier 5/4 to Tier 4 Retacrit soln 40000 unit/ml Tier 5/4 to Tier 4 Repatha Sureclick soaj 140 mg/ml Tier 5/4 to Tier 4 Repatha Pushtronex System soct 420 mg/3.5ml Tier 5/4 to Tier 4 Repatha sosy 140 mg/ml Tier 5/4 to Tier 4 Spritam tb3d 750 mg Tier 5 to Tier 4 Kaiser Permanente Georgia 5 Introducing Alvesco HFA: KP’s New Preferred Inhaled Corticosteroid (ICS) With the discontinuation of QVAR HFA from the market, Alvesco HFA has been selected as the preferred inhaled corticosteroid (ICS) at Kaiser Permanente. Alvesco HFA 80 mcg and 160 mcg were added to the Commercial formulary and moved to the preferred brand tier on the QHP formulary effective November 1, 2018.

Alvesco HFA should be prescribed for new starts on ICS therapy going forward. Patients currently taking QVAR HFA should be maintained on current therapy until the conversion program is implemented. The TSPMG Chief of Pulmonology and the Regional Pharmacy and Therapeutics Committee have approved the standing order for conversion from QVAR HFA to Alvesco HFA in support of this transition process. Requests for standing order signatures have been sent by e-mail.

Dose Strength QVAR Dose Alvesco Dose Adult Dosing 40 mcg 1 puff twice daily 80 mcg 1 puff once daily Low Dose 40 mcg 2 puffs twice daily 80 mcg 1 puff twice daily 80 mcg 1 puff twice daily Medium Dose 80 mcg 2 puffs twice daily 160 mcg 1 puff twice daily High Dose 80 mcg 3 to 4 puffs twice daily 160 mcg 2 puffs twice daily Pediatric Dosing Low Dose 40 mcg 1 puff once or twice daily 80 mcg 1 puff once daily 40 mcg 2 puffs twice daily Medium Dose 80 mcg 1 puff twice daily 80 mcg 1 puff twice daily High Dose 80 mcg 2 puffs twice daily 160 mcg 1 puff twice daily

6 Kaiser Permanente Georgia Appendix A: December 2018 Formulary Update New Step Therapy Medications for 2019

Behavioral Health

Brand Name Generic Trintellix Vortioxetine Ritalin LA CP24 Methylphenidate LA Daytrana Transdermal Patch Methylphenidate Focalin XR Dexmethylphenidate Evekeo Amphetamine

Women’s Health

Brand Name Generic Premarin Cream, tablets Conjugated Estrogen Combipatch Estradiol/Norethindrone Climara Pro Estradiol/Levonorgestrel Minivelle Transdermal Estradiol Alora Patch Estradiol Menostar Patch Estradiol Divigel Estradiol Elestrin gel Estradiol Evamist Solution Estradiol Femring Estradiol Safyral Estradiol/Dropspirenone/Levomefolate Natazia Estradiol/Dienogest

Endocrinology

Brand Name Generic Tresiba Flextouch Insulin Degludec Humulin R U-500 Soln Insulin Human Admelog Insulin Lispro Humulin 70/30 Kwikpen Insulin, Human Humalog Kwikpen 200 U/ml Insulin Lispro Glumetza Metformin ER Fortamet Metformin ER

Neurology

Brand Name Generic Requip XL Ropinirole Neupro Patch Rotigotine Frova Frovitriptan succinate Zelapar Selegiline

Page 1 Appendix A: December 2018 Formulary Update New Step Therapy Medications for 2019

Respiratory

Brand Name Generic Symbicort Budesonide/Formoterol Breo Ellipta Fluticasone/Vilanterol

Ophthalmology

Brand Name Generic Xiidra Soln Lifetegrast Zymaxid Gatifloxacin

Gastroenterology

Brand Name Generic Prepopik Sodium picosulfate/ magnesium oxide/citric acid Moviprep Polyethylene Glycol-Electrolyte Solution

Cardiovascular

Brand Name Generic Savaysa Edoxaban Eliquis Apixiban

Miscellaneous

Brand Name Generic Kapvay Clonidine ER tablets Myrbetriq Mirabegron Oxycontin 15 mg, 30 mg, 60 mg Oxycodone ER

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